Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF) CEO Phillip L’Huillier talked with Proactive about the company’s annual results and latest business update. He highlighted progress across Scancell’s clinical pipeline, particularly the SCOPE study in melanoma.
L’Huillier said the trial has answered four critical questions, including product selection, target patient population, administration, and dosing schedule. The company has chosen its iSCIB1+ candidate for further development, after observing “meaningful clinical benefit comes from administering our drug on top of standard of care.” He noted that the therapy is showing strong results in patients with specific HLA haplotypes, with the ability to use a screening tool to identify responders for future trials.
On efficacy, L’Huillier explained: “In our combined cohort, in the target population where we've got 72 patients, we're seeing a progression-free survival of 69% at 22 months. And if you compare that to the historic standard of care, it's 11.5 months.”
The CEO also discussed the Modi-1 programme in phase 2 for head and neck cancer and renal cell carcinoma, and progress on antiglycan antibodies, which are being advanced under a new subsidiary. Looking ahead, Scancell is preparing for regulatory discussions with the FDA, EMA and MHRA, while also engaging potential partners and investors.
Proactive: Philip, very good to speak with you again. You are out with your annual results and the business update this morning. Can you summarise the year and where you are?
Phillip L’Huillier: Yes good morning Stephen, and thank you for talking to me today, it's great to see you again. Scancell has had a great year. We've made good progress with our pipeline. We've made good progress with building out the organization for further development. And I think it's fair to say we've raised our profile. First and foremost to talk about is our lead program.
That's the SCOPE study in melanoma. And we've made amazing progress there. We read out some data recently. It's a translational study asking four key questions, really. One is which is the product we want to take forward for further development? What's the patient population that it works in and that we should use in a future study to work on? How do we administer this drug? And what's the dosing schedule?
We said we were going to answer those questions in this translational study. And we've done that. We've selected iSCIB1+ to move forward in further development. And it's amazing seeing meaningful clinical benefit come from administering our drug on top of standard of care, the checkpoint therapies.
There's two additional points that have come out of this. The analysis of the early data. One is, the drug was designed in the laboratory to work in patients with a certain profile, HLA haplotypes. And pleasingly it's doing in the clinic what was written on the tin. That gives us real confidence about moving forward. And then secondly, as we've now been able to identify that responder population, we have a selection tool, a tool we can use to screen patients that will respond, and use that screening tool to select the responder population in the next phase of development. And that's most likely going to be in hard success.
Proactive: What about other assets in your pipeline, Phil?
Phillip L’Huillier: The other assets in the pipeline. There's a second clinical program. It's called Modi-1 from the Moditope platform, a very unique mechanism of action. Currently in phase two, in two cohorts, head and neck cancer and renal cell carcinoma. We've shared some data on head and neck where we're seeing clinical benefit. We're recruiting well in the renal cohort.
And we anticipate sharing more data later in the year from that cohort. And then we also have an early pipeline, a preclinical pipeline of antibodies, antiglycan antibodies. Antibodies that hit the sugars on tumor cells. This pipeline we're now in the process of putting into a wholly owned subsidiary company that's designed to bring better focus, to the development focus resource into that new-co within Scancell, but also focus management to move that portfolio forward. And we're making good progress on doing that.
I should share with you just one of the results from our SCOPE study. We're now focused on PFS, progression free survival. That's what's important in the next stage of development. And that's what's important for the regulators, like the FDA and others, to get approval of a drug. In our combined cohort, in the target population where we've got 72 patients, we're seeing a progression free survival of 69% at 22 months. And if you compare that to the historic standard of care, it's 11.5 months, median 11.5 months. So that's 50% of 11.5 months, that's a whopping difference.
Proactive: Phil, what's next for Scancell?
Phillip L’Huillier: Well, we have progressed very efficiently, documentation for regulatory conversations. And we have regulatory conversations now scheduled for the next phase of development. The team has done a Herculean effort to get all the documentation ready and submitted. And so there's that piece now, regulatory conversation with the FDA and also hopefully EMA and MHRA about our study plans and our data that's coming out of our studies. Those conversations will happen over the next quarter.
And we're also knocking on as many doors as we can, talking to potential partners, and potential investors joining us, coming on board with us to move forward together for further development. And we will continue to execute the plans for further development, be it in partnership or going alone. So a lot going on and a really successful year.
Proactive: Phil I hope you'll continue to keep us posted on your progress. Thank you very much for taking the time today.